Gasec-20 Gastrocaps

Package Leaflet: Information for the Patient

Gasec-20 Gastrocaps, 20 mg, Capsules

Omeprazole

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others.
• The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Gasec-20 Gastrocaps and what is it used for
• 2. Important information before taking Gasec-20 Gastrocaps
• 3. How to take Gasec-20 Gastrocaps
• 4. Possible side effects
• 5. How to store Gasec-20 Gastrocaps
• 6. Contents of the pack and other information

1. What is Gasec-20 Gastrocaps and what is it used for

Gasec-20 Gastrocaps contains the active substance omeprazole. It belongs to a group of medicines called proton pump inhibitors. Their action is to reduce the amount of acid produced in the stomach.

Gasec-20 Gastrocaps is used to treat the following diseases and disorders:

In adults:

• Gastroesophageal reflux disease (GERD). This is when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers infected with bacteria called Helicobacter pylori. In such cases, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.
• Ulcers caused by medications known as non-steroidal anti-inflammatory drugs (NSAIDs). Gasec-20 Gastrocaps may also be used to prevent the development of ulcers when taking NSAIDs.
• Excessive stomach acid due to a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10 kg body weight

• Gastroesophageal reflux disease (GERD). This is when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of this disorder may include: regurgitation of stomach contents into the mouth (regurgitation), vomiting, and insufficient weight gain.

Children and adolescents over 4 years of age

• Ulcers infected with bacteria called Helicobacter pylori. If a child has this disease, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.

2. Important information before taking Gasec-20 Gastrocaps

When not to take Gasec-20 Gastrocaps

• If the patient has been diagnosed with an allergy to omeprazole or any of the other ingredients of this medication (listed in section 6);
• If the patient has been diagnosed with an allergy to medications containing other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• If the patient is taking clarithromycin and has impaired liver function;
• If the patient is taking a medication containing atazanavir, e.g., Reyataz (used to treat HIV infection);
• If the patient is taking a medication containing nelfinavir (used to treat HIV infection).

Do not take Gasec-20 Gastrocaps if any of the above points apply to the patient.

In case of any doubts, consult a doctor or pharmacist before starting to take Gasec-20 Gastrocaps.

Warnings and precautions

Before starting to take Gasec-20 Gastrocaps, discuss it with a doctor or pharmacist.

During treatment with Gasec-20 Gastrocaps, severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If any symptoms of these severe skin reactions occur, stop taking Gasec-20 Gastrocaps and seek medical help immediately.

Gasec-20 Gastrocaps may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Gasec-20 Gastrocaps, inform a doctor:

• Unexplained weight loss and difficulty swallowing
• Stomach pain or indigestion
• Vomiting blood or coffee ground-like material
• Passing black stools (stool discolored by blood)
• Severe or persistent diarrhea, as the use of omeprazole is associated with a small increase in the frequency of infectious diarrhea
• Severe liver problems
• In patients with reduced reserves or risk factors for reduced vitamin B12 absorption during long-term treatment with omeprazole. Omeprazole, like all medicines that inhibit gastric acid secretion, may reduce the absorption of vitamin B12
• If the patient has ever had a skin reaction after taking a medicine similar to Gasec-20 Gastrocaps, which reduces stomach acid production.
• Planned specific blood test (chromogranin A levels)
• During treatment with omeprazole, kidney inflammation may occur. Symptoms may include: decreased urine output or blood in the urine and (or)

allergic reactions, such as fever, rash, and joint stiffness. Inform a doctor about such symptoms.

In case of long-term use of Gasec-20 Gastrocaps (more than 1 year), the patient will most likely remain under close and regular medical supervision. During a visit to the doctor, report any new or unusual symptoms and circumstances.

During treatment with proton pump inhibitors, such as Gasec-20 Gastrocaps, especially for a period longer than one year, there may be an increased risk of hip, wrist, and spine fractures. Inform a doctor if the patient has osteoporosis or if the patient is taking corticosteroids (which may increase the risk of osteoporosis).

If the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking Gasec-20 Gastrocaps. Also, inform a doctor about any other side effects, such as joint pain.

This medication may affect the way the body absorbs vitamin B12, especially if taken for a long time. Inform a doctor if the patient notices any of the following symptoms, which may indicate low vitamin B12 levels:

• Extreme fatigue or lack of energy
• Numbness or tingling
• Painful or red tongue, mouth ulcers
• Muscle weakness
• Vision disturbances
• Memory problems, confusion, depression

Children

Some children with chronic diseases may require long-term treatment, although this is not recommended. Do not give this medication to children under 1 year of age or with a body weight of less than 10 kg.

Taking proton pump inhibitors may lead to a small increase in the risk of gastrointestinal infections with bacteria such as Salmonella and Campylobacter. In hospitalized patients, there is also a risk of infection with the bacterium Clostridium difficile.

Omeprazole may affect the results of some tests (chromogranin A levels). To avoid the influence of omeprazole on the test result, stop taking omeprazole 5 days before the test.

Gasec-20 Gastrocaps and other medications

Inform a doctor or pharmacist about all medications currently being taken or recently taken, as well as those planned to be taken. This includes medications available without a prescription. It is important because Gasec-20 Gastrocaps may affect the action of some other medications, and some other medications may affect the action of Gasec-20 Gastrocaps.

Do not take Gasec-20 Gastrocaps if taking a medication containing nelfinavir (used to treat HIV infection).

• Inform a doctor or pharmacist if taking any of the following medications:
• Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart rhythm disorders)
• Diazepam (used to treat anxiety, to reduce muscle tension, or to treat epilepsy)
• Phenytoin (used to treat epilepsy). If taking phenytoin, a doctor will need to monitor the patient's condition when starting or stopping Gasec-20 Gastrocaps
• Medications used to reduce blood clotting, such as warfarin or other vitamin K antagonists. A doctor will need to monitor the patient's condition when starting or stopping Gasec-20 Gastrocaps.
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in organ transplantation)
• Methotrexate (used in rheumatoid arthritis and some cancers) - if taking high doses of methotrexate, the doctor may temporarily stop Gasec-20 Gastrocaps.
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)
• Cilostazol (used to treat intermittent claudication)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots)
• Erlotinib (used to treat some cancers)

If a doctor has prescribed antibiotics amoxicillin and clarithromycin and Gasec-20 Gastrocaps to treat ulcers caused by Helicobacter pylori infection, it is very important for the patient to inform their doctor about any other medications being taken.

Gasec-20 Gastrocaps with food and drink

Gasec-20 Gastrocaps capsules can be taken with or without food. See section 3.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medication.

Omeprazole passes into breast milk, but its effect on the baby is unlikely when the medication is used at therapeutic doses. Whether a breastfeeding patient can take Gasec-20 Gastrocaps will be decided by a doctor.

Driving and using machines

Gasec-20 Gastrocaps does not affect the ability to drive or use machines. However, dizziness and blurred vision may occur (see section 4). If these symptoms occur, do not drive or operate machinery.

Gasec-20 Gastrocaps contains sucrose and sodium.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking this medication.

The medication contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Gasec-20 Gastrocaps

Always take this medication exactly as a doctor or pharmacist has told you. If you are not sure, consult a doctor or pharmacist.

A doctor will tell the patient how many capsules to take and for how long. This will depend on the patient's health and age.

Recommended dosages are presented below.

Use in adults:

Treatment of GERD symptoms, such as heartburn and acid regurgitation:

• If the doctor has found that the patient's esophagus has been slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. The doctor may recommend that the patient take a dose of 40 mg for another 8 weeks if the esophagus has not yet healed.
• The recommended dose after healing of the esophagus is 10 mg once a day.
• If the esophagus has not been damaged, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers (ulcers in the upper part of the small intestine):

• The recommended dose is 20 mg once a day for 2 weeks. The doctor may recommend taking the same dose for another 2 weeks if the ulcers have not healed by then.
• If the ulcer has not healed completely, the dose may be increased to 40 mg once a day for 4 weeks.

Treatment of gastric ulcers (stomach ulcers):

• The recommended dose is 20 mg once a day for 4 weeks. The doctor may recommend taking the same dose for another 4 weeks if the ulcers have not healed by then.
• If the ulcer has not healed completely, the dose may be increased to 40 mg once a day for 8 weeks.

Prevention of duodenal and gastric ulcers:

• The recommended dose is 10 mg or 20 mg once a day. The doctor may increase the dose to 40 mg once a day.

Treatment of duodenal and gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is 20 mg once a day for 4 to 8 weeks.

Prevention of duodenal and gastric ulcers during NSAID use:

• The recommended dose is 20 mg once a day.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The recommended dose of Gasec-20 Gastrocaps is 20 mg twice a day for one week.
• The doctor will also recommend that the patient take two antibiotics: amoxicillin and clarithromycin.

Treatment of excessive stomach acid production due to a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• The doctor will adjust the dose according to the individual needs of the patient and decide how long it is necessary to take Gasec-20 Gastrocaps.

Use in children and adolescents:

Treatment of GERD symptoms, such as heartburn and acid regurgitation:

• Children over 1 year of age and with a body weight of more than 10 kg can take Gasec-20 Gastrocaps. The dose for children depends on the child's body weight and will be individually recommended by a doctor.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• Children over 4 years of age can take Gasec-20 Gastrocaps. The dose for children depends on the child's body weight and will be individually recommended by a doctor.
• The doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

How to take Gasec-20 Gastrocaps

• It is recommended to take the capsules in the morning.
• The capsules can be taken with or without food.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain enteric-coated pellets whose coating prevents the breakdown of the medication by stomach acid. It is essential not to damage the pellets.

What to do if there are difficulties in swallowing the capsules (in an adult or child)

If an adult or child has difficulty swallowing the capsules:

• Open the capsule and swallow the contents directly, washing it down with a glass of water, or pour the contents into a glass of non-carbonated water, any acidic fruit juice (e.g., apple, orange, or grapefruit), or applesauce.
• Always mix the mixture just before drinking (the mixture will not be clear). Drink the mixture immediately after preparation or within 30 minutes.
• To ensure that the patient has taken the entire dose, rinse the glass with half a glass of water and drink the rinse liquid. Do not mix the medication with milk or carbonated water. The solid particles contain the medication - do not chew or crush them.

What to do if a higher dose of Gasec-20 Gastrocaps is taken than recommended

If a higher dose of Gasec-20 Gastrocaps is taken than prescribed by a doctor, contact a doctor or pharmacist immediately.

What to do if a dose of Gasec-20 Gastrocaps is missed

If a dose is missed because it was forgotten, take the dose as soon as remembered.

If it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

What to do if treatment with Gasec-20 Gastrocaps is stopped

Do not stop taking Gasec-20 Gastrocaps without consulting a doctor or pharmacist first.

In case of any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Gasec-20 Gastrocaps can cause side effects, although not everybody gets them.

In case of any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking Gasec-20 Gastrocaps and contact a doctor immediately.

Contact a doctor immediately.

• Sudden wheezing, swelling of the lips, tongue, or throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blistering or peeling. It can also cause large blisters and bleeding in the eyes, mouth, and genitals. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis. (very rare)
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome). (rare)
• Red, flaky, widespread rash with blisters under the skin and fever, usually appearing within the first few days of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems. (rare)

Other side effects include:

Common side effects (may affect up to 1 in 10 people)

• Headache
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating)
• Nausea or vomiting
• Mild stomach polyps

Uncommon side effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, feeling of tingling or numbness, feeling of drowsiness
• Feeling of spinning (vertigo)
• Changes in liver function test results
• Skin rash, hives, and itching
• General feeling of being unwell and lack of energy
• Fractures of the hip, wrist, or spine

Rare side effects (may affect up to 1 in 1,000 people)

• Blood problems, such as a decreased number of white blood cells or platelets. This can lead to weakness, bruising, or increased risk of infection
• Allergic reactions, sometimes severe, including swelling of the lips, tongue, or throat, fever, wheezing
• Low sodium levels in the blood. This can lead to weakness, vomiting, and muscle cramps
• Feeling agitated, confused, or depressed
• Changes in taste
• Vision problems, such as blurred vision
• Sudden shortness of breath or wheezing (bronchospasm)
• Dry mouth
• Oral thrush
• Infection known as "thrush", which can affect the intestines and is caused by fungi
• Liver problems, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue
• Hair loss (alopecia)
• Skin rash when exposed to sunlight
• Joint pain (arthralgia) or muscle pain (myalgia)
• Severe kidney problems (interstitial nephritis)
• Increased sweating

Very rare side effects (may affect up to 1 in 10,000 people)

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells) and pancytopenia (decreased number of red blood cells, white blood cells, and platelets)
• Aggression
• Seeing, feeling, or hearing things that are not there (hallucinations)
• Severe liver problems leading to liver failure and brain damage
• Sudden onset of severe rash or blistering of the skin, which can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Muscle weakness
• Enlargement of the breasts in men

Frequency not known (cannot be estimated from the available data)

• Intestinal inflammation (causing diarrhea)
• Low magnesium levels in the blood. If Gasec-20 Gastrocaps has been taken for more than three months, there is a possibility of low magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heart rate. If any of these symptoms are observed, inform a doctor immediately. Low magnesium levels can lead to low potassium or calcium levels in the blood (severe hypomagnesemia that can cause hypocalcemia). A doctor may recommend regular blood tests to monitor magnesium levels.
• Skin rash that can occur with joint pain
• Microscopic colitis

In very rare cases, Gasec-20 Gastrocaps may affect the number of white blood cells in the blood, leading to a lack of immunity. If a patient experiences an infection with symptoms such as fever with severe deterioration of general well-being or fever with symptoms of local infection, such as neck, throat, or mouth pain, or difficulty urinating, consult a doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) based on blood test results. It is essential for the patient to inform their doctor about the medication being taken.

Reporting side effects

If side effects occur, including any not listed in the leaflet, inform a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medication.

5. How to store Gasec-20 Gastrocaps

Keep this medication out of the sight and reach of children.

Do not take Gasec-20 Gastrocaps after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated on the packaging.

Store in a temperature below 30°C. Protect from moisture.

Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Gasec-20 Gastrocaps contains

• The active substance is omeprazole. Each Gasec-20 Gastrocaps capsule contains 20 mg of omeprazole.
• The other ingredients are: sucrose, povidone (K30), sodium lauryl sulfate, sodium glycolate starch (type A), trisodium phosphate, hypromellose, triethyl citrate, methacrylic acid, and ethyl acrylate copolymer (1:1), 30% dispersion, sodium hydroxide, titanium dioxide (E 171), talc Ingredients of the capsule shell:gelatin, erythrosine (E 127), indigo carmine (E132), titanium dioxide (E 171), quinoline yellow (E104).

What Gasec-20 Gastrocaps looks like and contents of the pack

Blue-orange capsules with white markings "O" on the cap and "20" on the body, containing white to beige micro-pellets.

Gasec-20 Gastrocaps capsules are packaged in HDPE (high-density polyethylene) bottles with a desiccant in the cap or in Al/Al blisters. The bottles and blisters are placed in a cardboard box.

Available pack sizes: 7, 14, 28, and 56 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer:

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, TEVA Pharma S.L.U., Poligono Industrial Malpica, Calle C. No 4, Zaragoza, 50016, Spain, Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany

To obtain more detailed information, contact the representative of the marketing authorization holder: Teva Pharmaceuticals Polska Sp. z o.o., tel. +48 22 345 93 00

Date of last revision of the leaflet: